CommunityB. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall – Hardware May Become UnresponsiveSoftware update may cause normal operation to stop with no visual warning signal. Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial ContaminationUPDATED 01/28/2011. Arixtra Starter Kits packaged with recalled prep pads. Use of contaminated alcohol prep pads, alcohol swabs or alcohol swabsticks could lead to life-threatening infections, especially in at risk populations. Arrow Intra-Aortic Balloon (IAB) Catheter Products: Class 1 Recall – Catheters Can Become Stuck in the SheathUPDATED 01/27/2011. Additional model & lot numbers added. Arrow Intra-Aortic Balloon (IAB) catheters can become stuck in the sheath and potential to cause delay in therapy, bleeding or arterial injury. Originally posted 12/29/2010 Breast Implants: FDA Review Indicates Possible Association With A Rare CancerData reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant. Fresenius Medical Care North America, CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor: Class I Recall – Potential for Kinking of Arterial LineKinking can cause the destruction of red blood cells which may result in serious injury and/or death. Multaq (dronedarone) – Drug Safety Communication: Risk of Severe Liver InjuryReports include two cases of liver failure leading to liver transplant Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety CommunicationNew labeling changes to emphasize the potential for severe liver failure and serious allergic reactions Celerite Slimming Capsules: Undeclared Drug IngredientProduct marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error – Reports of Accidental OverdoseMorphine sulfate oral solution ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product. Metronidazole Tablets, 250mg: Recall – Underweight TabletsUnderweight tablets may not contain the full amount of active ingredient within a single tablet. A consumer may not receive the prescribed dose, which may cause the infection the drug was intended to treat to worsen or recur, which could be life-threatening when treating severe infections. |
